Davita Trc Children’s Dialysis Center

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 1 of 4 patient (Pt. #6) susceptible to Hepatitis B (liver infection), the Facility failed to ensure that susceptible patients were monitored monthly as required for potential Hepatitis B infection. Findings include: 1. The Facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (revised April 2024), was reviewed and required, “...All patients will be routinely tested... Routine Surveillance Testing: ...Antibody [HBsAb] <10 = Susceptible = Monthly Antigen [HBsAg]...” 2. The clinical record of Pt. #6 was reviewed. Pt. #6 was admitted on 5/18/2023, with a diagnosis of ESRD. Pt. #6’s latest HBsAb level was 5 on 1/5/2024 indicating that Pt. #6 was susceptible to Hepatitis B infection. Pt. #6’s last HBsAg (antigen) result was dated 1/5/2024 and was negative. The record lacked documentation of additional monthly antigen labs after 1/5/2024, as required. The record indicated that Pt. #6 had received in-center hemodialysis treatments between 2/14/2024-4/5/2024. 3. An interview was conducted with the Manager of Clinical Services (E#6) on 4/9/2024, at approximately 1:25 PM. E#6 stated that the monthly antigen labs for Pt. #6 were missed and that they will draw the antigen lab the next time Pt. #6 comes in for treatment. E#6 stated that they will treat Pt. #6 as an unknown Hepatitis B isolation status until the results of the antigen are known.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 2 of 4 patients (Pts. #5 and #6) susceptible to Hepatitis B (liver infection), the Facility failed to ensure that patients were offered a booster dose of the vaccine. Findings include: 1. The Facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (revised April 2024), was reviewed and required, “...Patients who start hemodialysis may have a history of vaccination against hepatitis B. These persons should have responded to the vaccine when their immune status was normal, but if their hepatitis B surface antibody (HBsAb or anti-HBs) levels are less than (<) 10 mIU/mL [milli-international units per milliliter] when they begin dialysis, they should be revaccinated with a complete primary series...” 2. The clinical record of Pt. #5 was reviewed. Pt. #5 was admitted on 11/8/2023, with a diagnosis of end-stage renal disease (ESRD). Pt. #5 had a history of receiving one Hepatitis B Vaccination series between 2015-2016. Pt. #5’s HBsAb level was 6 upon admission on 11/8/2023. The record lacked documentation that Pt. #5 was offered another complete series of the vaccination. 3. The clinical record of Pt. #6 was reviewed. Pt. #6 was admitted on 5/18/2023, with a diagnosis of ESRD. Pt. #6 had a history of receiving one Hepatitis B Vaccination series in 2010. Pt. #6’s HBsAb level was 9 upon admission (lab result dated 2/22/2023). The record lacked documentation that Pt. #6 was offered another complete series of the vaccination. 4. An interview was conducted with the Manager of Clinical Services (E#6) on 4/9/2024, at approximately 1:25 PM. E#6 stated that both patients (Pts. #5 and #6) should have been offered another series and/or booster of the vaccine.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 staff (E#2-#4) observed performing CVC care, the Facility failed to ensure that appropriate infection control measures were used to when terminating dialysis treatment. Findings include: 1. The Facility’s procedure titled, “Pediatric Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” (revised October 2022), was reviewed and required, “...Perform at least a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines...” 2. During a tour of the dialysis treatment area on 4/8/2024, the following were observed: - At approximately 10:31 AM, a Patient Care Technician/PCT (E#4) was terminating dialysis treatment for a patient that had a CVC access site. E#4 disconnected the bloodlines from both access hubs and wiped each hub for only 3-4 seconds, instead of the required 15 seconds each. - At approximately 10:53 AM, Registered Nurse/RN (E#3) was terminating dialysis treatment for a patient that had a CVC. E#3 disconnected the bloodlines from both access hubs and then connected saline syringes to each hub without first disinfecting the hubs. E#3 flushed the lines with the saline and then disinfected the hubs afterwards. - At approximately 12:11 PM, RN (E#2) was terminating dialysis treatment for a patient that had a CVC. E#2 disconnected the bloodlines from both access hubs and then connected a saline syringe to flush the lines without first disinfecting the hubs. E#2 then administered heparin (a blood thinner) in both lines and then disinfected the hubs. 3. An interview was conducted with RN (E#2) on 4/8/2024, at approximately 1:30 PM. E#2 stated that E#2 was taught to disinfect the hubs only at the end to make sure they were clean before putting on the anti-microbial caps. E#2 stated that the hubs should be scrubbed with alcohol for at least 15 seconds and then let dry for another 10-15 seconds.”

“RO-MONITOR/ALARM/PREVENT UNSAFE H20 USE CFR(s): 494.40(a) 5.2.7 Reverse osmosis: alarm/prevent use of unsafe water Refer to RD62:2001, 4.3.7 Reverse osmosis: Reverse osmosis devices shall be equipped with on-line monitors that allow determination of rejection rates and product water conductivity. The product water conductivity monitor should activate audible and visual alarms when the product water conductivity exceeds the preset alarm limit. The audible alarm must be audible in the patient care area when reverse osmosis is the last chemical purification process in the water treatment system. Monitors that measure resistivity or TDS may be used in place of conductivity monitors. 6.2.7 Reverse osmosis: Reverse osmosis systems should be monitored daily using continuous-reading monitors that measure product water conductivity (or total dissolved solids (TDS)). 5.2.7 Reverse osmosis: Refer to RD62:2001, 4.3.7 Reverse osmosis: When a reverse osmosis system is the last chemical purification process in the water treatment system, it [should] include a means to prevent patient exposure to unsafe product water, such as diversion of the product water to drain, in the event of a product water conductivity or rejection alarm. This Standard is not met as evidenced by: 50411 Based on observation, interview, and document review, it was determined that , the Facility failed to ensure the water quality monitor alarm would be audible and visible during dialysis treatments if the quality deviates from the preset alarm limits. This had the potential to affect all patients receiving in-center hemodialysis treatments in the Facility. Findings include: 1. During a tour of the dialysis treatment area on 4/8/2024 at approximately 12:28 PM, the product water quality monitor alarm was noted to have packed gauze taped on it which covered the speaker and the lights. 2. An interview was conducted with Biomed (E#8) on 4/9/2024, at approximately 10:15 AM. E#8 stated that E#8 covered the alarm to muffle the sound while E#8 was disinfecting the loop because it keeps going off every 5 minutes. E#8 stated that it should have been removed after the disinfection was completed. E#8 stated that nothing should cover the alarm when treatments are in progress. 3. The water loop disinfection records were reviewed for 2024 and the last record of disinfection was completed on 3/14/2024 (over 3 weeks ago).”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 39802 Based on observation, document review, and interview, it was determined that for 2 of 2 staff (E#3 and E#5) observed performing machine setup, the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted according to the manufacturer’s instructions for use (IFU). This had the potential to affect all in-center dialysis patients as of 4/8/2024. Findings include: 1. During a tour of the dialysis treatment area on 4/8/2024, the following was observed: - At approximately 12:15 PM, a Patient Care Technician/PCT (E#5) obtained a sample of dialysate from the machine to test for pH. E#5 dipped the test strip in the sample then compared the strip to the color chart immediately instead of waiting as required. - At approximately 12:25 PM, a Registered Nurse (E#3) obtained a sample of dialysate for pH testing. E#3 dipped the pH test strip in the sample then compared the strip to the color chart immediately instead of waiting as required. - The bottles of strips being used during the tour had instructions to wait 10 seconds (older version of test strips). 2. The Facility’s procedure titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (revised February 2024), was reviewed and required, “...2. Obtain dialysate sample by using a disposable cup, then dip the strip in the solution for one (1) second. Or using a new syringe, obtain dialysate sample from sample port, then allow fluid to flow over the pad for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds [instructions for newer version of test strips], compare the color reaction on strip to the color chart on bottle to determine the closest match...” 3. An interview was conducted with E#5 on 4/8/2024, at approximately 12:16 PM. E#5 stated that pH must be tested manually prior to starting each patient treatment. E#5 stated that after dipping the strip in the sample, the result is read right away. 4. An interview was conducted with E#3 on 4/8/2024, at approximately 12:26 PM. E#3 stated that the result from the strip is read immediately (no waiting). 5. An interview was conducted with the Manager of Clinical Services (E#6) on 4/9/2024, at approximately 1:25 PM. E#6 stated that they removed the older bottles of pH test strips (with a 10 second wait time) and replaced them with the newer version to match the procedure. E#6 stated that going forward staff are expected to follow the instructions of waiting 20-25 seconds when doing the pH test with the new test strips. .”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 6 of 6 months (October 2023-March 2024) of microbial monitoring records reviewed, the Facility failed to ensure that dialysate samples were collected from at least two machines monthly. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policies titled, “Dialysate Culture Policy” and “Dialysate Endotoxin Testing Policy” (dated April 2024), were reviewed and required, “...Monthly sample sites include: 10% of all dialysis machines per month, always round up... If the 10% is less than two dialysis machines, two (2) machines should be sampled monthly...” 2. The Facility’s Microbial Records from 10/9/2023-3/14/2024 were reviewed and indicated that only one dialysis machine was sampled each month for dialysate cultures and endotoxins. 3. An interview was conducted with the Biomedical Technician (E#8) on 4/9/2024, at approximately 10:15 AM. E#8 stated that they have a total of 11 dialysis machines and that each machine is cultured annually. E#8 stated that E#8 only cultures one machine every month. 4. A telephone interview was conducted with the Biomedical Tech Supervisor (E#9) on 4/9/2024, at approximately 10:45 AM. E#9 stated that they sample 10% of the machines every month; however, the minimum is two dialysis machines every month.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50411 Based on document review and interview, it was determined that for 2 of 2 clinical records (Pt. #1 and Pt. #2) reviewed, the Facility failed to ensure that the fluid volume removed did not exceed the maximum ordered by the physician. Findings include: 1. The Facility’s policy titled “Chronic Hemodialysis: Pediatric Patients” (revised April 2023), was reviewed and required, “...29. The UF [ultrafiltration] rate must be ordered by physician...” 2. The clinical record of Pt. #1 was reviewed on 03/19/2024. Pt. #1 was admitted on 9/20/2023, with a diagnosis of end-stage renal disease (ESRD). Dialysis treatment orders active from 3/25/2024 - 4/8/2024 included 3 dialysis treatments per week; 180 minutes each treatment; with a maximum ultrafiltration rate (UFR) of 13 mL (milliliters) / kg (kilogram) / hr (hour). Seven consecutive treatment records from 3/25/2024-4/8/2024 were reviewed and included the following actual UFRs: - 3/25/2024 UFR = 15.0 mL/kg/hr (2 mL/kg/hr more than the maximum ordered) - 4/1/2024 UFR = 15.1 mL/kg/hr (2.1 mL/kg/hr more than the maximum ordered) - 4/3/2024 UFR = 15.2 mL/kg/hr (2.2 mL/kg/hr more than the maximum ordered) - The record lacked orders or notes from the physician to increase the maximum UFR. - The record lacked documentation to address why the maximum UFR ordered was exceeded and whether the physician was notified. 3. The clinical record of Pt. #2 was reviewed on 4/9/2024. Pt. #2 was admitted on 3/25/2024, with a diagnosis of end-stage renal disease (ESRD). Dialysis treatment orders dated 3/22/2024 included 3 dialysis treatments per week; 240 minutes each treatment; with a maximum ultrafiltration rate (UFR) of 13 mL (milliliters) / kg (kilogram) / hr (hour). Eight consecutive treatment records from 3/25/2024-4/8/2024 were reviewed and included the following: - 3/25/2024 UFR = 16.5 mL/kg/hr (3.5 mL/kg/hr more than the maximum ordered) - 3/27/2024 UFR = 16.5 mL/kg/hr (3.5 mL/kg/hr more than the maximum ordered) - 4/5/2024 UFR = 16.6 mL/kg/hr (3.6 mL/kg/hr more than the maximum ordered) - 4/8/2024 UFR = 20 mL/kg/hr (7 mL/kg/hr more than the maximum ordered) - The record lacked orders or notes from the physician to increase the maximum UFR. - The record lacked documentation to address why the maximum UFR ordered was exceeded and whether the physician was notified. 4. An interview was conducted with the Manager of Clinical Services (E#6) on 4/9/2024, at approximately 1:51 PM. E#6 stated that a doctor’s order is required if going over 13 ml/kg/hr.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 50411 Based on document review and interview, it was determined that for 2 of 2 (Pt. #3 and Pt. #4) clinical records reviewed for peritoneal dialysis, the Facility failed to ensure that treatment flowsheets that contained self-monitoring data were completed, as required. Findings include: 1. On 4/10/2024, the Facility’s policy titled, “Daily Home Treatment Record (Flowsheet)” (revised 9/2023), was reviewed and included, “...Purpose: To provide guidance for proper documentation of home peritoneal dialysis treatments ...to assist in assessing the patient’s response to peritoneal dialysis treatments ...5. Dialysis Home Treatment Record ...record submitted ...of applicable treatment data including, but not limited to ...vital signs ...Policy: ...3. ...this post-treatment data review will be verified by the Peritoneal Dialysis registered nurse documenting review in the medical record ...6. ...Based on what the patient submits, some follow up may be necessary and the patient’s health record must be updated to reflect any new information obtained.” 2. On 4/10/2024, the clinical record for Pt. #3 was reviewed. Pt. #3 was admitted on 7/12/2023 with a diagnosis of ESRD (end-stage renal disease). The dialysis home treatment records from 12/1/2023 to 2/7/2024 were reviewed and lacked documentation of any post-treatment weights. The record lacked documentation that patient/guardian re-education was conducted regarding the missing data. 3. On 4/10/2024, the clinical record for Pt. #4 was reviewed. Pt. #4 was admitted on 5/2/2022 with a diagnosis of ESRD. The dialysis daily home treatment records from 1/1/2024 to 2/29/2024 were reviewed and indicated that pre-treatment blood pressures were missed on 29 out of 60 treatments and pre-treatment weights were missed on 28 out of 60 treatments. The record also lacked any post-treatment weights and blood pressures. The record lacked documentation that patient/guardian re-education was conducted regarding the missing data. 4. On 4/10/2024 at approximately 11:50 AM, an interview with the Peritoneal Dialysis Registered Nurse (E # 7) was conducted. E #7 stated that the patients or their caregiver should record their weight and blood pressure before and after treatment on their flowsheets. E #7 stated that they speak with the patient’s caregiver to remind them to enter the necessary data and to bring in their log book at monthly clinic visits. E #7 stated they do not document that they spoke to the patient’s caregiver(s) regarding entering weight and blood pressure before and after treatment.”